BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2873576 · Received November 14, 2012

    Report

    Report Number
    3003793491-2012-00283
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 13, 2012
    Report Date
    October 15, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT OF THE UNIT STOPPING AFTER A COUPLE OF COMPRESSIONS WAS NOT CONFIRMED. HOWEVER, USER ADVISORY (UA) 2 WAS VERIFIED. LOAD CELL WAS REPLACED TO REMEDY THE PROBLEM. AUTOPULSE RESUSCITATION SYSTEM ARCHIVE FILE WAS REVIEWED. THE FILE INDICATED THAT ON (B)(6) 2012, WHICH IS THE DATE THE REPORTED EVENT OCCURRED, PLATFORM GAVE 530 COMPRESSIONS WITH A BATTERY THAT HAD LOW VOLTAGE (SERIAL # (B)(4)); UA 44 (BATTERY VOLTAGE TOO LOW DURING COMPRESSION) WAS DISPLAYED. ARCHIVE FILE ALSO INDICATED THAT A SECOND BATTERY (SERIAL # (B)(4)) WAS USED; IT GAVE 152 COMPRESSIONS, THEN STOPPED AND DISPLAYED UA 44. BASED ON THESE FINDINGS, IT IS LIKELY THAT BOTH BATTERIES HAD LOW VOLTAGE WHEN THE CUSTOMER BEGAN USING THEM. HOWEVER, BATTERIES WERE NOT RETURNED FOR EVAL. AFTER REPLACING THE LOAD CELL, PLATFORM RAN FOR 15 MINUTES WITH A TEST MANIKIN AND 5 MINUTES WITH A LARGE RESUSCITATION TEST FIXTURE (EQUAL FOR A 250 POUND PT) WITHOUT ANY ISSUES. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNIT WORKED ON PT THEN STOPPED AFTER A COUPLE OF COMPRESSION, REPLACED BATTERY AND AGAIN UNIT STOPPED AFTER A COUPLE OF COMPRESSIONS. CUSTOMER INDICATED THAT THE BATTERY HAD JUST BEEN CHARGED AND WAS NOT SURE OF THE USER ADVISORY CODE. CREW REVERTED TO MANUAL COMPRESSION. AFTER THE INCIDENT AND WHILE TESTING THE SYSTEM USING A MANIKIN, SYSTEM DISPLAYED USER ADVISORY 2. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other